NCT06164327

Study of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Multicenter, Open Phase Ib Study of the Safety and Efficacy of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: BeBetter Med Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open Phase Ib clinical study to evaluate the safety,efficacy and pharmacokinetics of BEBT-908 combined with Rituximab (R) or combined with Rituximab-Gemcitabine-Oxaliplatin (R-GemOx) or combined with Rituximab-Ifosfamide-Carboplatin-Etoposide (R-ICE) in the treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL).

Detailed description

This study sets up three cohorts, including BEBT-908 combined with R, BEBT-908 combined with R-ICE, and BEBT-908 combined with R-GemOx. The researchers decide whether to terminate the cohort study according to the safety and tolerability results of each cohort during the first cycle of medication. If the participants in the above three cohorts are unable to receive the treatment during the first cycle of medication, two alternative cohort studies will be conducted. Namely, BEBT-908 monotherapy (alternative cohort 1), adjustment of BEBT-908 combined with GemOx administration regimen (alternative cohort 2). The study process for each participant includes a screening period, a treatment period, and a post-treatment follow-up period. During treatment, participants are evaluated for tumors every 6 weeks, follow up after termination of treatment with efficacy follow-up every 6 weeks for those without disease progression and survival follow-up every 3 months until disease progression (PD), death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurred first).

Conditions

• Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	BEBT-908 for Injection	BEBT-908 for Injection,dosage of administration:15mg/m\^2 or 22.5mg/m\^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle,and 21 days as a cycle.
DRUG	Rituximab Injection	Rituximab Injection,dosage of administration:375 mg/m\^2,frequency and duration of administration:on the 1st day of each cycle, and 21 days as a cycle.
DRUG	Gemcitabine Hydrochloride for Injection	Gemcitabine Hydrochloride for Injection，dosage of administration:1g/m\^2,frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle.
DRUG	Oxaliplatin Injection	Oxaliplatin Injection，dosage of administration:100mg/m\^2,frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle.
DRUG	Etoposide Injection	Etoposide Injection,dosage of administration:100mg/m\^2，frequency and duration of administration:on the 1st,2nd and 3rd days of each cycle,and 21 days as a cycle.
DRUG	Ifosfamide for Injection	Ifosfamide for Injection,dosage of administration:5000mg/m\^2,24 hours of continuous intravenous drip，frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle.
DRUG	Carboplatin Injection	Carboplatin Injection，dosage of administration:based on AUC=5, single dose ≤800 mg，frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-10-31
• Completion: 2025-11-05
• First posted: 2023-12-11
• Last updated: 2023-12-11

Locations

1 site across 1 country: China